Although Cimerli had captured the highest utilization in the ranibizumab category, its continued availability in the US seems precarious. A press release by Formycon AG, part owner of the biosimilar’s developer (Bioeq), stated last week that ”Due to the increasing price discounts among ranibizumab providers in the US, Bioeq AG, the exclusive license holder of [Cimerli], is currently in discussions with its commercialization partner Sandoz AG regarding the future commercialization strategy for [Cimerli] in the US.” The company continued, “Based on the status of these discussions, Formycon currently expects that the commercialization of [Cimerli] will likely be temporarily paused.”
Cimerli was formerly being commercialized by Coherus, before the company sold off its biosimilar assets. According to data from the third quarter of 2024, Cimerli had top market share in the ranibizumab space, at 49% (Lucentis at 43% and Byooviz at 8%). However, average sales prices (ASPs) have been dropping rapidly in this category, with an overall 9% drop in Q1 2025 over the previous quarter. Cimerli’s ASP is down more than 35% in the 12 months prior.
Sandoz may be approaching this cautiously, based on its experience with the pegfilgrastim biosimilar Ziextenzo, which also saw rapidly falling ASPs.
Dr Stefan Glombitza, CEO of Formycon AG, stated in a press release that “Bioeq AG is therefore examining options for alternative commercialization strategies for the U.S. that combine economic success with long-term market presence.”
In other news from Formycon, the company announced that it was halting its phase 3 clinical trial development of FYB206, a Keytruda biosimilar candidate. After consultations with the FDA, the company determined that the late-stage was no longer needed, and a biologic license application could be successfully filed based on the phase 1 evidence (which was conducted in patients with malignant melanoma), in combination with its physiochemical characterization compared with the reference product.
Enno Spillner, Chief Financial Officer of Formycon AG, hailed the news, as yielding “significant financial benefits. By ending the phase 3 trial early, we expect savings in the high double-digit million range over the next few years.” This news also bodes well for the move to streamline biosimilar development, thereby reducing the costs to bring biosimilar products to commercialization stage.
